Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spectrum Medical , Ltd. · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
256 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Ca | Spectrum Medical , Ltd. | 2025-07-08 | 462 | 0 |
| K212657 | Quantum Heater-Cooler | Spectrum Medical , Ltd. | 2022-05-06 | 256 | 0 |
| K210669 | Quantum Mini Ventilation Module | Spectrum Medical , Ltd. | 2021-05-04 | 60 | 0 |
| K202733 | Quantum Ventilation Module | Spectrum Medical , Ltd. | 2020-10-16 | 28 | 0 |
| K202557 | Quantum Workstation 12 Elite | Spectrum Medical , Ltd. | 2020-10-02 | 29 | 0 |
| K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifug | Spectrum Medical , Ltd. | 2020-04-13 | 193 | 0 |
| K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occlude | Spectrum Medical , Ltd. | 2019-05-24 | 102 | 0 |
| K181942 | Quantum Ventilation Module | Spectrum Medical , Ltd. | 2018-10-18 | 90 | 0 |
| K181923 | Quantum Workstation 12.1 | Spectrum Medical , Ltd. | 2018-08-17 | 30 | 0 |
| K173834 | Quantum Pump Console | Spectrum Medical , Ltd. | 2018-05-25 | 158 | 2 |
| K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Ga | Spectrum Medical , Ltd. | 2018-03-28 | 127 | 0 |
| K163657 | Quantum Workstation | Spectrum Medical , Ltd. | 2017-01-18 | 26 | 0 |
| K091908 | M3 MONITOR | Spectrum Medical , Ltd. | 2009-07-10 | 15 | 1 |
| K072131 | M3 MONITOR | Spectrum Medical , Ltd. | 2007-08-17 | 15 | 0 |
| K071725 | M2 MONITOR | Spectrum Medical , Ltd. | 2007-07-11 | 16 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda